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临床试验/NCT05892692
NCT05892692已完成不适用

Nexus of Risk: Examining Sexual Assault, Alcohol Use, and Risky Sex Among College Women Through a Smartphone Application

University of New Mexico2 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
183
试验地点
2
主要终点
Sexual Experiences Survey

研究概览

简要总结

Sexual assault on college campuses has reached epidemic proportions, yet the etiological variables responsible for violence against women in these contexts remain unclear. Work on the situational precipitants of sexual assault has relied primarily on women's retrospective accounts, but research has shown that autobiographical memory is plagued by error. This study will use Ecological Momentary Assessment (EMA) to obtain a better understanding of the contextual determinants of sexual assault, as well as the co-occurrence of victimization, risky sex, and substance use. These findings will inform the development of an Ecological Momentary Intervention (EMI) that will provide college women with personalized feedback about their level of risk for victimization and related adverse events. The effectiveness of EMA/EMI in decreasing rates of sexual assault, risky sexual behavior, and substance use then will be evaluated relative to an EMA-only and an assessment-only control group.

详细描述

Sexual assault is a significant public health problem. The sequelae of victimization involve both mental and physical health problems (Bedard-Gilligan et al., 2011; Hughes et al., 2010), and once victimized, women are at significant increased risk for revictimization (Classen et al., 2005; Messman-Moore & Long, 2003). Sexual assault has reached epidemic proportions on college campuses, with undergraduate women reporting high rates of victimization (Krebs et al., 2007). Alcohol use is intimately intertwined with sexual violence (Abbey, 2011), as well as high-risk sexual behavior (Scott-Sheldon et al., 2010). Work on the situational precipitants of sexual assault has relied primarily on women's retrospective accounts, even though autobiographical memory is plagued by error (Bradburn et al., 1987).

One way to obtain ecologically valid observations of these precipitants may be through Ecological Momentary Assessment (EMA). EMA data are collected in near realtime and are considered to have greater validity than retrospective accounts (Shiffman et al., 2008). The primary aim of this study will be to use EMA to obtain a better understanding of the contextual determinants of sexual assault, as well as the co-occurrence of victimization, risky sex, and substance use. This basic work then will inform the development of an Ecological Momentary Intervention (EMI) for college women to reduce their risk. EMI would permit an opportunity to intervene prior to and during high-risk situations by providing women with personalized feedback about their level of risk for victimization and related adverse events. The secondary aim of this study will be to conduct a randomized controlled trial (RCT) comparing the effectiveness of EMA/EMI, relative to EMA-only and an assessment only control group, in decreasing rates of sexual assault, risky sexual behavior, and substance use. This RCT will be prospective in design and target women who are at increased risk for assault (freshman). If supported, this work would offer college campuses a cost-effective, easily disseminated approach to preventing assault and other adverse consequences.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • (1) being between the ages of 18-24, as women younger than 25 are at highest risk for victimization (American Academy of Pediatrics, 2001); (2) being unmarried and interested in dating opposite sex partners, as the tasks given at baseline describe situations that unmarried, heterosexual, or bisexual college women might face when interacting socially with men; (3) being a binge drinker, defined by SAMHSA as having at least 4 drinks on one occasion in the past month, since drinking heavily (Testa et al., 2010) increases women's risk for victimization; (4) having engaged in sexual intercourse at least once, as these women will likely be at increased risk relative to non-sexually active women; and (5) being able to use a smartphone.

排除标准

  • Participants who fail to meet all eligibility requirements listed above, or who report an AUDIT score greater than 16 or elevated mood symptoms are excluded from participating.

结局指标

主要结局

Sexual Experiences Survey

时间窗: Six Weeks

Measures victimization at a six month follow-up

The Rutgers Alcohol Problem Index

时间窗: Six Weeks

The RAPI is a 23-item questionnaire developed specifically to evaluate alcohol-related problems of adolescents. The measure has high internal consistency, with alpha = .92 in a sample of adolescents from 12 to 21.

Sexual Risk Measure

时间窗: Six Weeks

The SRM was developed by Consultant Bryan (Schmiege et al., 2009) and measures condom use, frequency of intercourse, and sexual behavior under the influence of alcohol. A risky sex index is calculated such that higher scores indicate riskier sexual behavior.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Yeater

Dr. Elizabeth Yeater

University of New Mexico

研究点 (2)

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